| Trial ID: | L6760 |
| Source ID: | NCT01206647
|
| Associated Drug: |
Metformin And Saxagliptin
|
| Title: |
Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Metformin and Saxagliptin
|
| Outcome Measures: |
Primary: percentage of patients with stable HbA1c, 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals | Secondary: impact of the switch on:, - Biomarkers of insulin resistance and ß-cell function, 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - Biomarkers of cardiovaskular risk, 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - Patient treatment satifaction, 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - Treatment costs, 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - Requirement of 3rd line OAD pioglitazone as rescue drug, 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - oral Glucose Tolerance Test (oGTT), 26 ± 2 weeks (baseline to postbaseline values)|impact of the switch on:, - Macrophagen activation (in a subpopulation at site 01 ikfe GmbH), 26 ± 2 weeks (baseline to postbaseline values)
|
| Sponsor/Collaborators: |
Sponsor: ikfe-CRO GmbH | Collaborators: AstraZeneca|IKFE Institute for Clinical Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-02
|
| Completion Date: |
2011-02
|
| Results First Posted: |
|
| Last Update Posted: |
2010-09-22
|
| Locations: |
Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann, Bochum, 44869, Germany|Zentrum für klinische Studien Dresden, GWT-TUD GmbH, Dresden, 01307, Germany|Gemeinschaftspraxis Partner der Gesundheit, Essen, 45355, Germany|IKFE Institute for Clinical Research and Development, Mainz, 55116, Germany|Zentrum für Diabetes und Gefäßerkrankungen, Münster, 48145, Germany|Diabetes Zentrum Neuwied, Neuwied, 56564, Germany|ikfe Studiencenter Potsdam GmbH, Potsdam, 14469, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01206647
|
